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Protocol to Permit the Acquisition of Circulating Tumor Material in Pancreatic Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471170
Recruitment Status : Suspended (on hold due to COVID-19)
First Posted : June 15, 2015
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Tracking Information
First Submitted Date June 11, 2015
First Posted Date June 15, 2015
Last Update Posted Date April 15, 2020
Actual Study Start Date September 10, 2015
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 12, 2015)
Collection of blood and tissue samples from subjects with pancreatic diseases [ Time Frame: 3 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Protocol to Permit the Acquisition of Circulating Tumor Material in Pancreatic Diseases
Official Title Protocol to Permit the Acquisition of Circulating Tumor Material in Pancreatic Diseases
Brief Summary The purpose of this study is to collect blood samples to detect potential markers of pancreatic cancer in the blood and link these findings to medical and health information. Information from this study may help to provide insight into the detection of pancreas cancer in the blood before it can be found by other methods or provide a method of monitoring the status of pancreatic cancer throughout a treatment course. Another purpose of this study is to collect blood to create a biobank.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
The frequency of research blood collection will not exceed 60 mL in a 1 week period and will not occur more frequently than 4 times in an 8 week period.
Sampling Method Probability Sample
Study Population subjects with pancreatic diseases
Condition Pancreatic Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: June 12, 2015)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2023
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. The subject must be a patient at the Hospital of the University of Pennsylvania

    • The subject must be under evaluation and/or treatment for a pancreatic disease
    • The subject must be under evaluation and/or treatment for a non-pancreatic disease. For example, patients undergoing routine colonoscopy within the clinical practice will be asked to consent to provide control samples.
  2. The subject must be able to provide informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf
  3. The subject must be 18 years of age or older

Exclusion Criteria:

  1. The subject or acceptable surrogate does not provide informed consent
  2. Subject is a prisoner
  3. Subject is under 18 years of age
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02471170
Other Study ID Numbers UPCC 02215
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Abramson Cancer Center of the University of Pennsylvania
Study Sponsor Abramson Cancer Center of the University of Pennsylvania
Collaborators Not Provided
Investigators
Principal Investigator: Peter O'Dwyer, MD Abramson Cancer Center of the University of Pennsylvania
PRS Account Abramson Cancer Center of the University of Pennsylvania
Verification Date April 2020